BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINUTEMAN G3R

    MDR report key: 12365861 · Received August 24, 2021

    Report

    Report Number
    MW5103491
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    August 17, 2021
    Report Date
    August 23, 2021
    Manufacturer
    SPINAL SIMPLICITY LLC
    Product Code
    PEK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    DURING IMPLANTATION THE INSERTION DEVICE AND/ OR IMPLANT BROKE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260485 MINUTEMAN G3R SPINOUS PROCESS PLATE PEK SPINAL SIMPLICITY LLC 10-0019-000 M44664

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention